Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Epidural Morphine for Postoperative Analgesia After Total Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03203967
Recruitment Status : Completed
First Posted : June 29, 2017
Last Update Posted : June 4, 2018
Sponsor:
Information provided by (Responsible Party):
Dong-Xin Wang, Peking University First Hospital

Brief Summary:
Single femoral nerve blockade combined with patient-controlled intravenous analgesia are used for postoperative analgesia for patients after TKA in the hospital of the investigators. Although this method provides acceptable analgesia, the incidence of opioid-associated side effects is relatively high. Low-dose epidural morphine is commonly used in postoperative analgesia after cesarean section, and the effect of single dose morphine lasts more than 20 hours, with low incidences of itching, nausea, vomiting, and respiratory depression. The investigators hypothesize that, for patients undergoing TKA, the addition of low-dose epidural morphine to single femoral nerve block and intravenous opioids can improve the postoperative analgesia, reduce the consumption of intravenous opioids and decrease opioid-associated side effects.

Condition or disease Intervention/treatment Phase
Adult Patients Total Knee Arthroplasty Epidural Analgesia Femoral Nerve Block Analgesic Adverse Reaction Procedure: Epidural morphine Procedure: Epidural placebo Procedure: Single femoral nerve block Drug: Intravenous morphine analgesia Not Applicable

Detailed Description:
Total knee arthroplasty (TKA) is an important therapy for patients with serious knee osteoarthritis in order to improve quality of life and relieve pain. But a large number of patients who undergo this surgery experience moderate to severe postoperative pain. Previously, the investigators used single femoral nerve blockade combined with patient-controlled intravenous analgesia for postoperative analgesia for patients after TKA. Although this method provides acceptable analgesia, the incidence of opioid-associated side effects is relatively high. Low-dose epidural morphine is commonly used in postoperative analgesia after cesarean section, and the effect of single dose morphine lasts more than 20 hours, with low incidences of itching, nausea, vomiting, and respiratory depression. The investigators hypothesize that, for patients undergoing TKA, the addition of low-dose epidural morphine to single femoral nerve block and intravenous opioids can improve the postoperative analgesia, reduce the consumption of intravenous opioids and decrease opioid-associated side effects.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effect of Low-dose Epidural Morphine Combined With Single-injection Femoral Nerve Block on Postoperative Analgesia in Patients After Total Knee Arthroplasty
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : May 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Epidural morphine
  1. Epidural morphine (2 mg morphine in 5 ml normal saline) is administered through the epidural catheter at the end of surgery.
  2. Single femoral nerve block is performed with 20 ml of 0.5% ropivacaine under the guidance of ultrasonography and nerve stimulator after surgery.
  3. Intravenous morphine analgesia is provided with a patient-controlled analgesia pump which is established with 100 ml of 0.5 mg/mL morphine, programmed to deliver a 2 ml bolus with a lockout interval of 8-10 min and a background infusion of 0.5 mL/h.
Procedure: Epidural morphine
2 mg of morphine (0.4 mg/ml morphine in 5 ml normal saline) is administered through the epidural catheter at the end of surgery.

Procedure: Single femoral nerve block
Single femoral nerve block is performed with 20 ml 0.5% ropivacaine under the guidance of ultrasonography and nerve stimulator after surgery.

Drug: Intravenous morphine analgesia
Intravenous morphine analgesia is provided with a patient-controlled analgesia pump which is established with 100 ml of 0.5 mg/ml morphine, programmed to deliver a 2 ml bolus with a lockout interval of 8-10 min and a background infusion of 0.5 ml/h.

Placebo Comparator: Epidural placebo
  1. Epidural placebo (5 ml normal saline) is administered through the epidural catheter at the end of surgery.
  2. Single femoral nerve block is performed with 20 ml of 0.5% ropivacaine under the guidance of ultrasonography and nerve stimulator after surgery.
  3. Intravenous morphine analgesia is provided with a patient-controlled analgesia pump which is established with 100 ml of 0.5 mg/mL morphine, programmed to deliver a 2 ml bolus with a lockout interval of 8-10 min and a background infusion of 0.5 mL/h.
Procedure: Epidural placebo
5 ml normal saline is administered through the epidural catheter at the end of surgery.

Procedure: Single femoral nerve block
Single femoral nerve block is performed with 20 ml 0.5% ropivacaine under the guidance of ultrasonography and nerve stimulator after surgery.

Drug: Intravenous morphine analgesia
Intravenous morphine analgesia is provided with a patient-controlled analgesia pump which is established with 100 ml of 0.5 mg/ml morphine, programmed to deliver a 2 ml bolus with a lockout interval of 8-10 min and a background infusion of 0.5 ml/h.




Primary Outcome Measures :
  1. Percent of patients with moderate to severe pain (Numeric Rating Scale pain score of 4 or higher) [ Time Frame: Until 48 hours after surgery. ]
    Pain severity is evaluated with Numeric Rating Scale (NRS, an 11-point scale where 0 = no pain and 10 = the worst pain) both at rest and with movement.


Secondary Outcome Measures :
  1. NRS pain scores (at rest and with movement) at various timepoints after surgery [ Time Frame: At 6, 12, 24, 36 and 48 hours after surgery. ]
    Pain severity is evaluated with Numeric Rating Scale (NRS, an 11-point scale where 0 = no pain and 10 = the worst pain) both at rest and with movement.

  2. Cumulative morphine consumption [ Time Frame: Until 48 hours after surgery. ]
    Cumulative morphine consumption during 48 hours after surgery.

  3. Recovery of motor function of the lower limb from blockade [ Time Frame: At the end of the surgery and at 0.5, 6, 12, 24, 36, 48 hours after surgery. ]
    Modified Bromage scale (0 = no blockade: extended limb lift off the bed; 1 = flexion/extension at knee and ankle joint; 2 = no flexion/extension at knee or ankle joint; 3 = complete blockade).

  4. Time to begin functional exercise and ground walking [ Time Frame: During hospital stay, up to 1 week after surgery. ]
    Time to begin functional exercise and ground walking

  5. Patient's satisfaction with analgesia [ Time Frame: At 48 hours after surgery. ]
    Evaluated in 5 scale, i.e., very satisfactory, satisfactory, neither satisfactory nor unsatisfactory, unsatisfactory, and very satisfactory.

  6. Length of stay in hospital after surgery [ Time Frame: Until hospital discharge up to 30 days after surgery. ]
    Length of stay in hospital after surgery

  7. Incidence of postoperative complication [ Time Frame: Until 30 days after surgery. ]
    Incidence of postoperative complication within 30 days after surgery.

  8. The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index [ Time Frame: At 30 days after surgery. ]
    Evaluated with the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index.

  9. Quality of life (SF-12) at 30 days after surgery [ Time Frame: At 30 days after surgery. ]
    Evaluated with Short-Form Health Survey-12 (SF-12) at 30 days after surgery.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients (age of 18 years or older);
  • American Society of Anesthesiologists classification I-III;
  • Scheduled to undergo unilateral TKA under combined spinal and epidural anesthesia.

Exclusion Criteria:

  • Age higher than 90 years old;
  • Presence of any contraindication to neuraxial block or peripheral nerve block;
  • Continuous use of opioid analgesics during the last month;
  • Unable to understand Numeric Rating Scale for pain evaluation or existence of language barrier;
  • Severe renal insufficiency (requirement of renal replacement therapy);
  • History of asthma;
  • Recruited in another clinical trials.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03203967


Locations
Layout table for location information
China, Beijing
Peking University First Hospital
Beijing, Beijing, China, 100034
Sponsors and Collaborators
Peking University First Hospital
Investigators
Layout table for investigator information
Principal Investigator: Dong-Xin Wang, MD,PhD Peking University First Hospital

Publications:
Pulos N, Sheth N. Perioperative pain management following total joint arthroplasty. Ann Orthop Rheumatol. 2014;2(3):1029.Google Scholar
Bonica J. Postoperative pain. In: Bonica J, editor. The Management of Pain. 2nd ed. Philadelphia: Lea & Febiger; 1990. p. 461-80.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Dong-Xin Wang, Professor and Chairman, Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT03203967    
Other Study ID Numbers: 2017[1308]
First Posted: June 29, 2017    Key Record Dates
Last Update Posted: June 4, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Dong-Xin Wang, Peking University First Hospital:
Adults
Unilateral TKA
Single femoral nerve block
Low-dose epidural morphine
Effect of postoperative analgesia
Quality of life
Additional relevant MeSH terms:
Layout table for MeSH terms
Agnosia
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Morphine
Ropivacaine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Local
Anesthetics